Trial document




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  DRKS00010191

Trial Description

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Title

Patient Expectation and Treatment Outcomes of Acupuncture in Patients with Chronic Low Back Pain

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Trial Acronym

PATE (Pain Acupuncture Treatment Expectation)

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URL of the Trial

http://www.iki.usz.ch/Documents/Flyer_Akupunktur_2016_FINAL.pdf

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Brief Summary in Lay Language

This project aims at assessing patients’ expectations and determining their relationship to treatment outcomes. Chronic low back pain is a highly prevalent medical condition and responsible for high treatment costs. Patients with chronic low back pain often use interventions from complementary medicine, such as acupuncture. Acupuncture reduces chronic low back pain. Patients’ treatment expectations also proved to be relevant for the treatment success. However, studies taking these expectations into account are limited so far and valid instruments to measure patients’ expectations are still missing. The project aims to develop an instrument to measure patients’ expectations, to practically implement it and to test the effect of patients’ expectations on the treatment outcome. Patients with chronic low back pain will be included in the study and receive acupuncture treatment.
The project aims at contributing to a better understanding of the impact of expectations and the mechanisms of acupuncture. The knowledge of such working mechanisms can later be implemented into practice. The instrument to measure patients’ expectations can also be applied in other clinical contexts, where such patient variables are also relevant for treatment outcomes.

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Brief Summary in Scientific Language

Chronic low back pain (CLBP) is a highly prevalent medical condition and CLBP patients often use acupuncture. That acupuncture reduces chronic pain has been shown in clinical trials and meta-analyses. Patients with higher expectation for a favorable acupuncture outcome had more pain reduction regardless of the received acupuncture or sham acupuncture. In clinical practice, explanations for potential benefits and side effects of acupuncture vary.
Aim: This study wants to develop an instrument to assess treatment expectations, measure treatment expectations and investigate the impact of patients’ treatment expectation before treatment, experience of side effects during treatment and pain reduction after Treatment.
Methods: This study will include 150 patients with CLBP. All patients will receive acupuncture (8 sessions over 4 weeks). The primary intervention effects will be assessed 1) by measuring pain intensity after the last acupuncture treatment and 2) scoring side effects and their intensity for all acupuncture treatments. Secondary outcomes are, among others, self-reported health.

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Organizational Data

  •   DRKS00010191
  •   2016/03/30
  •   [---]*
  •   yes
  •   Approved
  •   KEK-ZH-Nr. 2015-0511, Kantonale Ethikkommission Zürich
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   M54.8 -  Other dorsalgia
  •   M54.9 -  Dorsalgia, unspecified
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Interventions/Observational Groups

  •   Acupuncture (8 sessions over 4 weeks)
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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

back pain (numeric Rating scale, NRS, 0 - 10), 4 weeks after treatment start;
side effects of acupuncture (side effect score), 4 weeks after treatment start;

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Secondary Outcome

Back pain (NRS, 0 - 10), 2 weeks after treatment start, Follow-up after 6 months;
Health (PROMIS 29), 2 and 4 weeks after treatment start, Follow-up after 6 months;
Working alliance (WAI-SR). 4 weeks after treatment start;
Rescue medication (diary), weekly
Perceived Sensitivity to Medication (PSM scale), 4 weeks after treatment start
Bothersomeness pain (NRS, 0-10), 2 and 4 weeks after treatment start, Follow-up after 6 months;

Additional measures:
Optimism (Life orientation test, LOT), before the first treatment; Empathy with the physician (Consultation and relational empathy, CARE), before the first treatment

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Countries of Recruitment

  •   Switzerland
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/03/24
  •   150
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

Male and female patients aged 18 to 65 years with chronic non-specific low back pain (CLBP)
according to Deyo et al. (2014) with an average pain severity of at least 4 on a 0-10 numeric
rating scale and at least half of the days per months with pain in the last 6 months will be
eligible for this study.

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Exclusion Criteria

Patients will be excluded if they had have acupuncture treatment within the last 12 months; are
breast-feeding or are known pregnant, have a known blood coagulation disorder or take of
coagulation inhibiting drugs with the exception of aspirin. Furthermore they are excluded in case
of their CLBP being caused by a known malignant disease, trauma, the presence of a known
rheumatic or autoimmune disorder, a history or planned surgery of the spinal column of the low
back in the next 6 months, regular intake of analgesics (> once per week) because of additional
disease, intake of centrally-acting analgesics, regular intake of corticosteroids or injections with
corticosteroids within the last 8 weeks before randomization (specified in a studyspecific SOP), or a history of severe acute or chronic disorders that do not allow participation in the therapy.
Further exclusion criteria are known alcohol or substance abuse, insufficient German
language skills, current application for a pension claim.

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Addresses

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    • Institut für komplementäre und integrative MedizinUniversitätsSpital Zürich
    • Ms.  Prof. Dr.  Claudia  Witt 
    • Sonneggstrasse 6
    • 8091  Zürich
    • Switzerland
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    • Institut für komplementäre und integrative MedizinUniversitätsSpital Zürich
    • Mr.  PD Dr.  Jürgen  Barth 
    • Sonneggstrasse 6
    • 8091  Zürich
    • Switzerland
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    • UniversitätsSpital ZürichInstitut für komplementäre und integrative Medizin
    • Ms.  Alexandra  Kern 
    • Sonneggstrasse 6
    • 8091  Zürich
    • Switzerland
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    •   +41 (0)44 255 50 46
    •   [---]*
    •   pate at usz.ch
    •   [---]*
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Sources of Monetary or Material Support

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    • Schweizerischer Nationalfonds (SNF)
    • Wildhainweg 3
    • 3001  Bern
    • Switzerland
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Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.